{"id":1699806,"url":"https://alion.io/job/hologic-design-assurance-engineer-2","title":"Design Assurance Engineer 2","company":{"id":720267,"name":"Hologic","domain":"hologic.com","url":"https://alion.io/company/hologic","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":12,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-04T05:45:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":126000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1812},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T14:04:06Z","employer_posted_date":"2026-09-30","last_verified_at":"2026-10-04T22:38:13Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Design Assurance Engineer 2 will provide design assurance support for new product development by ensuring that design controls, verification and validation, risk management, regulatory compliance, and product change activities are effectively implemented and maintained.\nResponsibilities\nProvide design assurance support for new product development and on-market medical devices.\nFacilitate application of design controls throughout product development and sustaining product activities.\nSupport manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.\nParticipate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.\nSupport test method validation as part of verification and validation activities.\nParticipate in sustaining product projects by ensuring projects are well-defined, remain on task, and include required verification, validation, and risk management activities.\nCollaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with applicable standards and internal policies.\nCoordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.\nAnalyze product issues efficiently, including defining problems and evaluating potential impact.\nAssess product change requests for design impact and determine required supporting documentation for implementation.\nKnowledge\nFDA Quality System Regulations, especially Design Control requirements.\nISO 13485 and Medical Device Directive requirements.\nISO 14971 Risk Management requirements.\nVerification and validation requirements for regulated products.\nRequirements analysis, including development of measurable and testable specifications.\nFamiliarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards.\nPreferred knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.\nSkills\nAbility to support design control activities in a regulated medical device environment.\nAbility to review and assess product and project documentation for compliance.\nStrong analytical skills for evaluating product issues, risks, and design change impacts.\nAbility to coordinate cross-functional activities related to risk management and health risk assessments.\nEffective project team participation and collaboration.\nClear communication of compliance assessments and technical findings.\nAbility to define, review, and evaluate verification and validation requirements.\nBehavior\nCollaborative and team-oriented, especially when working with R&D and project teams.\nDetail-oriented with a strong focus on compliance and documentation quality.\nProactive in identifying design, regulatory, and risk-related concerns.\nObjective and analytical when evaluating product issues and change requests.\nOrganized and able to keep projects focused and on task.\nActing as a compliance advocate while maintaining effective communication with stakeholders.\nExperience\nTechnical Bachelor’s Degree is required.\n2+ years of experience preferred, ideally in the medical device industry.\nExperience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.\nWhy join Hologic?\nWe are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.\nThe annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.\nAgency and Third-Party Recruiter Notice\nAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.\nHologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.","description_format":"text","description_chars":4461,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Hospitals & Health Systems"],"lifecycle":[{"event":"open","at":"2026-10-02T13:01:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 30 · green card filings: 7","filings_12m":30,"filings_prev_12m":31,"green_card_filings_12m":7,"median_offered_wage_usd":133986,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":25,"reasons":["conf:1","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-04T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/hologic-design-assurance-engineer-2","json_url":"https://alion.io/job/hologic-design-assurance-engineer-2.json","meta":{"generated_at":"2026-10-05T00:55:54Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1205,"day_limit":5000,"remaining_today":3795,"minute_limit":60,"resets_at":"2026-10-06T00:00:00Z"}}}